Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.
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The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.
The CDC released the first real world data February 15 in a Morbidity and Mortality Weekly Report (MMWR) that infants younger than 6 months were overall 61% less likely to be hospitalized from COVID-19 if their mothers were vaccinated during pregnancy through completion of a 2-dose primary mRNA COVID-19 vaccine series with either Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax).
Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.
The solution, available immediately to all large health plans, is meant to simplify care for patients with complex conditions.
The FDA is postponing its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for February 15. Pfizer notified the agency about new data from its ongoing clinical trial.
Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.
The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.
BioMatrix Specialty Pharmacy is now included as a preferred provider in AscellaHealth’s home infusion pharmacy network.
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Patients who are immunocompromised are advised to get a three-dose series and then a fourth dose.
Drugs works by interfering with the classical complement pathway.
The Biosimilars Forum Board of Directors recently appointed Juliana M. Reed as its new executive director and Formulary Watch got the scoop from Reed first hand.
The agency said data from a trial testing the PI3 kinase inhibitor as a treatment for chronic lymphocytic leukemia prompted the concern.
FDA approved the first generic version of Restasis 0.05% eye drops to increase tear production in patients whose production is suppressed due to dry eye.
Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.
FDA is requiring postmarketing surveillance studies to further assess the risk of myocarditis and pericarditis from the vaccine, which is being sold under the brand name Spikevax.
The new therapy treats patients with unresectable or metastatic uveal melanoma.
Price increases on promising non–small cell lung cancer drugs despite evidence price competition raise concerns about affordability.
Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.
The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.
More than $250 million worth of counterfeit and illegally resold versions of Gilead Sciences’ HIV medications Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) were distributed to pharmacies and patients.
Experts says Regeneron and Eli Lilly’s antibody treatments won’t work against omicron, but Florida Gov. Ron DeSantis calls the FDA’s decision to pause the emergency use authorization “just wrong.”
The new Medi-Cal Rx program that debuted Jan. 1 has alarmed health clinics that say the state's Medicaid will lose money and have to cut services.
The company joins the wide array of online pharmacy services, such as Amazon Pharmacy, that have popped up in recent years. Cuban has also launched a namesake PBM.
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